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Testing the reliability and validity of DSM-IV-TR and ICSD-2 insomnia diagnoses. Results of a multitrait-multimethod analysis.检验《精神疾病诊断与统计手册》第四版修订版(DSM-IV-TR)和《国际睡眠障碍分类》第二版(ICSD-2)失眠症诊断的可靠性和有效性。多特质-多方法分析结果
Arch Gen Psychiatry. 2011 Oct;68(10):992-1002. doi: 10.1001/archgenpsychiatry.2011.64. Epub 2011 Jun 6.
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Efficacy and Safety of Doxepin 1 mg and 3 mg in a 12-week Sleep Laboratory and Outpatient Trial of Elderly Subjects with Chronic Primary Insomnia.多塞平 1 毫克和 3 毫克治疗老年慢性原发性失眠患者 12 周睡眠实验室和门诊试验的疗效和安全性。
Sleep. 2010 Nov;33(11):1553-61. doi: 10.1093/sleep/33.11.1553.
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Treatment of elderly primary insomnia patients with EVT 201 improves sleep initiation, sleep maintenance, and daytime sleepiness.EVT 201 治疗老年原发性失眠患者可改善入睡、睡眠维持和日间嗜睡。
Sleep Med. 2010 Jan;11(1):23-30. doi: 10.1016/j.sleep.2009.07.012. Epub 2009 Nov 28.
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Efficacy and safety of 6-month nightly ramelteon administration in adults with chronic primary insomnia.每晚服用雷美替胺6个月对成人慢性原发性失眠的疗效和安全性。
Sleep. 2009 Mar;32(3):351-60. doi: 10.1093/sleep/32.3.351.
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Efficacy and safety of doxepin 1 mg, 3 mg, and 6 mg in elderly patients with primary insomnia: a randomized, double-blind, placebo-controlled crossover study.多塞平1毫克、3毫克和6毫克治疗老年原发性失眠患者的疗效和安全性:一项随机、双盲、安慰剂对照交叉研究。
J Clin Psychiatry. 2008 Oct;69(10):1557-64. doi: 10.4088/jcp.v69n1005. Epub 2008 Oct 7.
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Effect of gaboxadol on sleep in adult and elderly patients with primary insomnia: results from two randomized, placebo-controlled, 30-night polysomnography studies.加波沙朵对成年和老年原发性失眠患者睡眠的影响:两项为期30晚的随机、安慰剂对照多导睡眠图研究结果
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Efficacy and safety of zolpidem-MR: a double-blind, placebo-controlled study in adults with primary insomnia.唑吡坦缓释片的疗效与安全性:一项针对原发性失眠成人患者的双盲、安慰剂对照研究。
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多导睡眠图标准定义失眠的敏感性和特异性。

Sensitivity and specificity of polysomnographic criteria for defining insomnia.

机构信息

VA and Duke University Medical Centers, Durham, NC 27705, USA.

出版信息

J Clin Sleep Med. 2013 May 15;9(5):481-91. doi: 10.5664/jcsm.2672.

DOI:10.5664/jcsm.2672
PMID:23674940
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3629323/
Abstract

STUDY OBJECTIVES

In recent years, polysomnography-based eligibility criteria have been increasingly used to identify candidates for insomnia research, and this has been particularly true of studies evaluating pharmacologic therapy for primary insomnia. However, the sensitivity and specificity of PSG for identifying individuals with insomnia is unknown, and there is no consensus on the criteria sets which should be used for participant selection. In the current study, an archival data set was used to test the sensitivity and specificity of PSG measures for identifying individuals with primary insomnia in both home and lab settings. We then evaluated the sensitivity and specificity of the eligibility criteria employed in a number of recent insomnia trials for identifying primary insomnia sufferers in our sample.

DESIGN

Archival data analysis.

SETTINGS

Study participants' homes and a clinical sleep laboratory.

ADULTS

76 with primary insomnia and 78 non-complaining normal sleepers.

MEASUREMENTS AND RESULTS

ROC and cross-tabs analyses were used to evaluate the sensitivity and specificity of PSG-derived total sleep time, latency to persistent sleep, wake after sleep onset, and sleep efficiency for discriminating adults with primary insomnia from normal sleepers. None of the individual criteria accurately discriminated PI from normal sleepers, and none of the criteria sets used in recent trials demonstrated acceptable sensitivity and specificity for identifying primary insomnia.

CONCLUSIONS

The use of quantitative PSG-based selection criteria in insomnia research may exclude many who meet current diagnostic criteria for an insomnia disorder.

摘要

研究目的

近年来,基于多导睡眠图的入选标准越来越多地被用于确定失眠研究的候选人,这在评估原发性失眠的药物治疗的研究中尤其如此。然而,PSG 识别失眠患者的敏感性和特异性尚不清楚,也没有关于应用于参与者选择的标准集的共识。在本研究中,使用档案数据集来测试 PSG 测量在家庭和实验室环境中识别原发性失眠个体的敏感性和特异性。然后,我们评估了一些最近的失眠试验中使用的入选标准在识别我们样本中的原发性失眠患者的敏感性和特异性。

设计

档案数据分析。

设置

研究参与者的家庭和临床睡眠实验室。

成人

76 名原发性失眠患者和 78 名无抱怨的正常睡眠者。

测量和结果

使用 ROC 和交叉表分析来评估 PSG 衍生的总睡眠时间、持续睡眠潜伏期、睡眠后觉醒和睡眠效率用于区分原发性失眠成人与正常睡眠者的敏感性和特异性。没有一个单一的标准能够准确地区分 PI 和正常睡眠者,而且最近试验中使用的标准集都没有表现出可接受的敏感性和特异性,无法识别原发性失眠。

结论

在失眠研究中使用基于定量 PSG 的入选标准可能会排除许多符合当前失眠障碍诊断标准的人。